Patient leaflet - Nobivac Bb
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR
Nobivac Bb lyophilisate and solvent for suspension for cats
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
Intervet International B.V.
Wim de Korverstraat 35
NL – 5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Bb lyophilisate and solvent for suspension for cats
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3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each dose (0.2 ml) of reconstituted suspension contains:
Lyohpilisate:
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106. 3–108.3 colony forming units (CFU) of live Bordetella bronchiseptica strain B-C2
Solvent:
Water for injections
Lyophilisate: Off-white or cream-coloured pellet
Solvent: clear colourless solution
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4. INDICATION(S)
For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
The duration of immunity is up to 1 year.
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5. CONTRAINDICATIONS
Do not use in pregnant or lactating queens.
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6. ADVERSE REACTIONS
After administration, occasionally sneezing, coughing, mild and transient discharge from the eyes or nose may occur. After overdose, identical signs appear particularly in very young susceptible kittens. In cats that show more severe signs, appropriate antibiotic treatment may be indicated.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Cats.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
For nasal use.
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9. ADVICE ON CORRECT ADMINISTRATION
Allow the solvent to reach room temperature. Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided. Shake well after addition of the solvent. Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat’s nostrils.
The head of the cat should be held with its nose pointing upward and its mouth closed, so that it is forced to breathe through its nostrils. Place the syringe in front of one of the nostrils and carefully administer the whole contents of the syringe into the nasal cavity via this nostril. The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children
Store at 2 – 8°C. Protect from light.
Do not use after the expiry date which is stated on the label.
Shelf-life after reconstitution according to directions: 4 hours
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12. SPECIAL WARNINGS
Only healthy cats should be vaccinated.
Sneezing by cats after administration does not adversely affect the efficacy of the veterinary medicinal product.
Do not mix with any other veterinary medicinal product except the solvent supplied for use with the product.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Do not administer during antibiotic treatment, or in conjunction with any other intranasal veterinary medicinal product.
If any antibiotic is administered within one week after vaccination, the vaccination should be repeated after the antibiotic treatment has been completed.
Vaccinated animals can spread the Bordetella bronchiseptica vaccine strain for six weeks; in individual cases for at least one year. Intermittent spreading is possible as well.
Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats that are in close contact with immunocompromised humans are not vaccinated with this vaccine. Such individuals should also be aware that cats can shed the organism for up to 1 year after vaccination.
Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs. Other animals, such as rabbits and small rodents, have not been tested.
Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
In case of accidental self-administration seek medical advice immediately and show the package leaflet or the label to the physician.
The import, sale, supply and/or use of Nobivac Bb for cats is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. Any person intending to import, sell, supply and/or use Nobivac Bb for cats must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Dispose of waste material that has had contact with the active substance by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED
Detailed information on this product is available on the website of the European Medicines Agency,.
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15. OTHER INFORMATION